federal_register: 2012-8908
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts | regulation_id_numbers |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2012-8908 | Draft Guidelines on Biologics Quality Monitoring: Testing for the Detection of Mycoplasma Contamination | Notice | The International Cooperation on Harmonization of Technical Requirements for the Registration of Veterinary Medicinal Products (VICH) has developed a draft guideline titled "Testing for the Detection of Mycoplasma Contamination." This draft guideline identifies stages of manufacture where products are to be tested and test procedures used to detect the presence of Mycoplasma contamination. Because the guidelines apply to final product and master seed/cell testing in veterinary vaccines regulated by the Animal and Plant Health Inspection Service under the Virus-Serum-Toxin Act, we are requesting comments on the scope of the guideline and its provisions so that we may include any relevant public input on the draft in the Agency's comments to the VICH Steering Committee. | 2012-04-13 | 2012 | 4 | https://www.federalregister.gov/documents/2012/04/13/2012-8908/draft-guidelines-on-biologics-quality-monitoring-testing-for-the-detection-of-mycoplasma | https://www.govinfo.gov/content/pkg/FR-2012-04-13/pdf/2012-8908.pdf | Agriculture Department; Animal and Plant Health Inspection Service | 12,22 | The International Cooperation on Harmonization of Technical Requirements for the Registration of Veterinary Medicinal Products (VICH) has developed a draft guideline titled "Testing for the Detection of Mycoplasma Contamination." This draft guideline... |